A Phase I Study of Lurbinectedin plus Paclitaxel in Patients with Advanced Solid Tumors

Protocol

13-170

Full Title

Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination with Weekly Paclitaxel, With or Without Bevacizumab, in Patients with Selected Advanced Solid Tumors

Phase

I

Purpose

Lurbinectedin (also known as PM01183) is an investigational drug that causes cancer cells to die by binding to and causing breaks in their DNA (genetic material). The drug has been shown to shrink or control tumor growth in patients with various cancer types, including cancers of the breast, lung, and ovaries.

Laboratory studies have shown that the drug paclitaxel, which has been used for many years to treat cancer, helps lurbinectedin to control cancer cell growth and to cause cancer cell death. In this study, researchers want to find the highest dose of lurbinectedin and paclitaxel that can be given together in patients with lung, ovarian, cervical, endometrial, breast, head and neck (squamous cell), or germ cell cancers, or adenocarcinoma of unknown primary. Both drugs are given intravenously (by vein).

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

Patients must have advanced or inoperable lung, ovarian, cervical, endometrial, breast, head and neck (squamous cell), or germ cell cancers, or carcinoma of unknown primary.

Patients may have had up to three prior regimens of chemotherapy for advanced disease, but may not have had weekly paclitaxel or nanoalbumin-bound paclitaxel for advanced disease.

A sufficient amount of time (generally three to four weeks) must have passed since completion of prior treatment and entry into the study.

Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.

This study is open to patients ages 18 to 75.

For more information and to inquire about eligibility for this study, please contact Dr. Alexander Drilon at 646-888-4206.

Clinical Trials

Clinical trials can offer you access to a new, experimental treatment before it is available to most patients. Joining a clinical trial is also a way to make a valuable contribution toward the fight against cancer.